Address:34-14 MAEHAMA, HIROISHI-CHO,GAMAGORI, AICHI,JP
Device Description : The AUTO REFRACTOMETER AR-F is a medical device which measures objective refract The AUTO REFRACTOMETER AR-F is a medical device which measures objective refractive errors of the patient’s eye. This device also offers retroillumination mode for observing the condition of the ocular media, and measures the amplitude of accommodation.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refr The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive errors and corneal curvature radius of the patient’s eye. This device also offers retroillumination mode for observing the condition of the ocular media, and measures the amplitude of accommodation.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The ST-6100 is the system table on which the Nidek Refractor RT-6100, RT-3100, o The ST-6100 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually operated refractor such as the RT-600 or SLY-100*1 is installed. The system table allows chart presenting devices (SSC-370, CP-770, SC-1600 series), auto refractometers, lensmeters (LM-1800 series, LM-7 series), and slit lamp (SL-1800 TAKAGI M2/M4) to be combined into an ophthalmic workstation. The system table consists of a refractor head lift arm equipped with a refractor head and a motorizedmain table. While compact, it includes a motorized table with a stroke up to 180 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 40 types of trial lenses. Trays for mounting an auto refractometer, or for mounting a slit lamp and auto refractometer are also available.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The ST-600 is the system table on which the Nidek Refractor RT-6100, RT-3100, or The ST-600 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually operated refractor such as the RT-600 or SLY-100 is installed. The system table allows chart presenting devices (SSC-370, CP-770, SC-1600 series), auto refractometers, lensmeters (LM-1800 series, LM-7 series) to be combined into an ophthalmic workstation. The system table consists of a refractor head lift arm equipped with a refractor head and a motorized main table. While compact, it includes a motorized table with a stroke up to 200 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 35 types of triallenses.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Nidek Space Saving Chart SSC-100 is a refraction device used in combination The Nidek Space Saving Chart SSC-100 is a refraction device used in combination with the refractor head of the RT-6100 or RT-3100.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Nidek CHART PROJECTOR CP-9 is a chart presenting device that can achieve ref The Nidek CHART PROJECTOR CP-9 is a chart presenting device that can achieve refraction at a distance of 2.9 m to 6.1 m (standard 5 m).The main unit is operated by a wireless remote control or the control box on a motorized refractor (RT).
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : No
Device Description : delivery unit is connected to the laser photocoagulator and YAG laser system to delivery unit is connected to the laser photocoagulator and YAG laser system to comprise the photocoagulation system and to treat affected areas using a slit lamp.The photocoagulation system enables photocoagulation using a green laser beam (532 nm) or photodisruption using a Nd:YAG laser beam (1064 nm, hereafter referred to as “YAG laser beam”) or SLT laser (532 nm, for YC-200 S plus only) while observing the patient’s eye with the slit lamp.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : No